MAUDE Adverse Event Report: Stryker GmbH Hoffmann II Connecting Rod Micro D3 x 120mm; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Catalog Number	50796120
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, cracks were identified in hoffmann micro carbon rods during inspection.
Event or Problem Description
Cracks identified in hoffmann micro carbon rods.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Based on investigation, the root cause was attributed to a design related issue.This is a confirmed design issue and has already been investigated in an nc, and a capa has been initiated for further action.Based on the information reviewed to date, we reserve the right to conclude that no further investigation is necessary.Based on the aforementioned information, a dhr review was not considered necessary, since the root cause of the event affects all lots in the market.In addition, a device evaluation was not deemed necessary, as similar devices have already been inspected and tested within the scope of the nc.

• Brand Name: Hoffmann II Connecting Rod Micro D3 x 120mm
• Common Device Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50418749
• Report Number: 0008031020-2026-01310
• Device Sequence Number: 10659979
• Product Code: KTT
• UDI-Device Identifier: 04546540389947
• UDI-Public: 04546540389947
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 50796120
• Device Lot Number: unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2827-2026
• Patient Sequence Number: 1
• Patient Sex: Unknown